Business
Eledon Pharmaceuticals Reports Third Quarter 2022 Operating and Financial Results
Received FDA clearance of IND application to evaluate tegoprubart in a Phase 2 trial for the prevention of rejection in patients receiving a kidney transplant
About this update from Eledon Pharmaceuticals, Inc.
[{"type":"text","content":"Received FDA clearance of IND application to evaluate tegoprubart in a Phase 2 trial for the prevention of rejection in patients receiving a kidney transplant Dosed initial two patients in ex-U.S. Phase 1b trial evaluating tegoprubart for the prevention of rejection in patients receiving a kidney transplant Received FDA clearance of IND application to evaluate tegoprubart for the treatment of IgA Nephropathy (IgAN) Conference call today at 4:30 PM ET IRVINE, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported its third quarter 2022 operating and financial results and reviewed recent business highlights. “The third quarter was highlighted by significant progress on both the clinical and regulatory fronts, highlighted by IND application clearances to evaluate tegoprubart in the U.S. for both the prevention of rejection in kidney transplant patients as well as the treatment of IgAN,” said David Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “These milestones, coupled with the continued enrollment progress in our ongoing clinical trials, leave us well positioned to provide valuable insights into tegoprubart’s broad therapeutic potential. We look forward to sharing the initial open label data from both our kidney and islet cell transplant studies, as well as our IgAN study, in the first quarter of next year.” Third Quarter 2022 and Recent Corporate Developments Received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) to evaluate tegoprubart for the treatment of IgAN. Eledon plans to open U.S. sites under this IND as part of its ongoing global Phase 2a clinical trial evaluating tegoprubart for the treatment of IgAN. Including the U.S., the trial has now received regulatory clearances in 11 countries with plans to expand the study into China in 2023. Multiple patients in the Phase 2a study have begun receiving treatment with tegoprubart.Received IND application clearance from the FDA for a controlled, Phase 2 trial of tegoprubart for the prevention of organ rejection in persons receiving a kidney transplant. The IND-opening Phase 2 study will be a multicenter, open-label, 2-arm, active comparator safety, pharmacokinetic, and efficacy study that will enroll approximately 120 participants (60/arm) undergoing kidn...